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FDA Releases Several MoCRA Support Tools
(Thursday, January 11, 2024) Under the Modernization of Cosmetic Regulations Act of 2022 (MoCRA), cosmetic manufacturers are subject to increased registration and GMP compliance rules. This week FDA released several electronic tools to assist cosmetic manufacturers in submitting information required under MoCRA. These include electronic forms for providing manufacturer information, product listing, and other commitments expected to be submitted electronically to the FDA. MoCRA is a major change in cosmetic regulation in the US. Under MoCRA, five requirements apply to all manufacturers of cosmetics. First, all facilities must register with the FDA, second, all products manufactured at a cosmetic facility must be individually listed with the FDA. Third, facilities must comply with the FDA’s GMP requirements for cosmetic products which include quality systems and release testing. Fourth, all ingredients included in a given cosmetic product and the final product must demonstrate safety either by referencing credible scientific information about their safety or using data from specific safety studies conducted with them. Fifth, companies must commit to reporting adverse events related to their products by setting up safety monitoring systems. The FDA tools released this week are intended to help with electronic registration and product listing. In these electronic forms, the manufacturers certify that they meet the GMP, safety, and adverse event reporting requirements. The forms can also be printed and mailed to the FDA but electronic submission through the Cosmetics Direct portal is preferred. Although MoCRA came into effect on 29th of December 2023, the FDA has given the industry an additional 6 months to comply, until July 1, 2024. After that date, any cosmetic manufacturers who are not compliant will be subject to enforcement actions such as product recalls and other punitive actions. MoCRA registration requirements do not apply to small businesses defined as those manufacturers with gross annual sales of less than $1 million. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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